1.Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines.
Hong-jiao LI ; Li-yun HE ; Bao-yan LIU
China Journal of Chinese Materia Medica 2015;40(12):2461-2463
The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
Drugs, Chinese Herbal
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adverse effects
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economics
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therapeutic use
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Humans
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Medicine, Chinese Traditional
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Product Surveillance, Postmarketing
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methods
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Quality Control
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Randomized Controlled Trials as Topic
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Respiratory Tract Infections
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drug therapy
2.Peripheral blood stem cells transplantation for treatment of chronic lower limb ischemia
Guokai YANG ; Xiaoming HE ; Yan BAO ; Yong YANG ; Jia WAN
International Journal of Surgery 2010;37(10):657-659
Objective To investigate the efficiency of autologous transplantation of peripheral blood stem cell for treatment of patients with chronic lower limb ischemia. Methods Forty-six patients with chronic lower limb ischemia were treated by autologous peripheral blood stem cell transplantation. Results Fortytwo patients had pain relief on legs, and cold and cool feelings in lower limbs disappeared. Thirty-five patients had pain relief on feet, and 29 of them had disappearance of cold and cool feelings. Due to necrosis in middle and lower part of leg, 4 patients took extremity amputation after 4 weeks of the transplantation. In the 42 patients who kept their legs 3 months after transplantation, the distance of anginacruris extended from (87. 45 ±41.22) m to (348.52 ± 147.24) m, skin temperature increased from(28.52 ±0.51 ) ℃ to(33.56±0.62) ℃ ,and ankle-brachial index (ABI) increased from(0.48 ±0.06)to(0.75 ±0.07). There were statistical differences, and the scores of the distance of anginacruris, skin temperature, and ABI after transplantation were better than before. six months after transplantation autobiography of lower extremity was used, and neonatal lateral vessels of different degrees were found in 37 patients. Conclusion Autologous transplantation of peripheral blood stem cell is a simple, safe, and effective method, especially in treating patients with lower limb ischemia in which no arterial reconstruction is feasible.
3.Several Sterilizing Methods for Paraffin Oil:A Comparative Experiment
Yan REN ; Guohua CHEN ; Jianfang BAO ; Dongping HE
Chinese Journal of Nosocomiology 1994;0(01):-
OBJECTIVE To study effective and convenient method for paraffin oil sterilization.METHODS By using carrier qualitative germicidal test,to compare pressure steam sterilization,dry heat sterilization and cobalt-60(gamma)-ray radiation sterilization to test the sterilizing effect and operating procedure.RESULTS Pressure steam sterilization was unable to achieve 100% sterilizing effect,whether we extended the time or use the intermittent(sterilization).After dry heat or radiation sterilization processes,no microorganism was found.CONCLUSIONS Effect of sterilization with dry heat or radiation sterilization is trustable,but its packing,operation and equipment are requested strictly,and pressure steam sterilization may be not good for paraffin oil.
4.Mechanism of Chromium Accumulation by Fused Yeast
Sen LI ; Hua YIN ; Bao-Yan HE ; Jin-Shao YE ; Hui PENG ; Yan LONG ; Na ZHANG ;
Microbiology 2008;0(11):-
The mechanism of chromium accumulation and microstructure transformation of the fused yeast were studied in this paper.The result showed that the process of Cr6+ reduction and adsorption was accom-panied by the H+ consumption.The main adsorptive groups on the strain surface included amino,hydroxyl,phosphate group and amide,among which phosphate group played vital role in the chromium accumulation.The removal rate of chromium and reduction rate of hexavalent chromium declined 70% and 46%,respec-tively,when phosphate group was masked.During the adsorption process the chromium ions complexed on the surface of fused yeast was transported into the cell wall and combined with inclusion to form steady spe-cies and this took 90 min to reach the equilibrium.The biosorption and reduction of Cr on the cell surface would alter microstructure of cell surface,reduce cell membrane potential and increase cell membrane per-meability.
5.Identification of liposoluble constituents in Yushu tablets by UPLC-ESI-IT-TOF/MS.
Zhong-ting XIA ; Li-ying BAO ; Yi HE ; Yan-ru DENG ; Shui-ping ZHOU
Acta Pharmaceutica Sinica 2015;50(5):587-593
In order to identify the chemical constituents of Yushu tablets comprehensively, we studied the chemical constituents of CHCl3 extract from Yushu tablets by the ultra performance liquid chromatography-electrospray ionization-ion trap-time of flight mass spectrometry (UPLC-ESI-IT-TOF/MS). It showed that there were more than 100 compounds separated, and forty-nine peaks among these were identified on the basis of high resolution mass spectrometry data and literature data reported. Determination of twelve peaks was further confirmed by standard substances. These components assigned to the different plant sources mainly included phenylpropanoids, triterpenoids, quinones and m-trihydroxybenzene compounds. By analyzing the chemical components of CHCl3 extract from compound Chinese medicine Yushu tablets comprehensively, this study provided the foundation for studying chemical components, pharmacodynamic substance and quality control of Yushu tablets.
Chromatography, High Pressure Liquid
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Chromatography, Liquid
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Drugs, Chinese Herbal
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analysis
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Spectrometry, Mass, Electrospray Ionization
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Tablets
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Tandem Mass Spectrometry
6.Evaluation of the rapid trehalose test for the identification of the Candida glabrata
Chun HE ; Qin LIN ; Zhenying BAO ; Yanhong MENG ; Xiaomei QI ; Hong HUA ; Zhimin YAN
Journal of Peking University(Health Sciences) 2015;(1):186-190
Objective:To explore a rapid and cost-effective method for identification of Candida gla-brata through the comparison of two different methods , using molecular methods of sequencing as gold standard.Methods:From our clinic, 200 strains of suspected Candida glabrata were collected during the last 3 years and selected after incubation in CHROMagar Candida medium for 48 h.By comparing the results of the CHROMagar Candida medium, the identification of the rapid trehalose test for different kinds of strains were analyzed under incubation in the tubes for 3 h, 6 h, and 24 h at 37 ℃and 42 ℃, respectively .All the strains were identified to species level by methods of sequencing .The optimal time and temperature of the trehalose test for the identification of Candida glabrata were assessed .Two different methods, CHROMagar Candida medium and the rapid trehalose test , in identification of Candi-da glabrata were compared.Results:In all the 200 strains, Candida glabrata ferment trehalose with 3 h incubation under 42 ℃ were the optimal time and temperature for fermenting trehalose .The accuracy , sensitivity, and specificity of the rapid trehalose test were 99.00% (198/200), 98.66% (147/149) and 100.00%(51/51).The accuracy rate of CHROMagar Candida medium was 79.50%(159/200), the sensitivity and specificity were only 89.93%(134/149) and 49.02%(25/51), however, compared with the domestic current popular methods , the rapid trehalose test had better time efficiency ratio .Con-clusion:The evaluation results suggest that the rapid trehalose test has advantages in terms of operational convenience and low cost , and the results can be obtained in 3 h.Therefore, it has application value in clinical laboratory .
7.Innovating Experimental Teaching System and Improving Students’ Practicing Ability——Experimental Teaching Reformation of Environmental Microbiology
Bao-Yan HE ; Hua YIN ; Jin-Shao YE ; Hua-Ming QIN ; Li-Li WANG ;
Microbiology 2008;0(10):-
A new experiment curriculum system of environmental microbiology was established centering on applied microbiology in environmental protection field and emphasizing on design and research experi- ments to motivate the students’ interests for the course, which helped them to improve their ability of think- ing independently and creatively as well as their practicing ability.
8.Electronic cigarette use among adolescents in Ningxia Hui Autonomous Region
LI Yan Ni ; GUAN Su Zhen ; HE Bao Fu ; MA Yu Qin
Journal of Preventive Medicine 2021;33(3):259-263
Objective:
To investigate the status of electronic cigarette use among adolescents in Ningxia Hui Autonomous Region, and to provide evidence for tobacco control in adolescents.
Methods:
Based on the 2019 National Youth Tobacco Epidemic Monitoring Program, multistage proportional sampling method was used to select middle school students from Ningxia Hui Autonomous Region. A questionnaire revised by Chinese CDC was used to collect the general information, the cognition and use of electronic cigarettes, and the access to advertising of electronic cigarettes and related products.
Results:
Totally 9 019 questionnaires were distributed, 8 401 valid ones were recovered, and the response rate was 93.2%. The rates of electronic cigarette use and attempt among students were 4.3% and 13.4%. The rates of electronic cigarette use and attempt in male students were 7.7% and 22.9%, which were higher than that in female students (0.8% and 3.8%, P<0.05) . The rates of electronic cigarette use and attempt varied in different schools ( P<0.05 ), which were higher in vocational high school students ( 11.5% and 26.8% ). Among 246 students who used electronic cigarettes, 30.1% did not thought electronic cigarettes contained nicotine, while 60.2% did not know whether electronic cigarettes contain nicotine. In the past 30 days, 27.0% of the students had seen the advertisements of electronic cigarettes and related products, mainly through TV, store, supermarket, convenience store, grocery store, electronic cigarette experience store or retail store.
Conclusions
The rates of electronic cigarette use and attempt among adolescents in Ningxia Hui Autonomous Region are 4.3% and 13.4%. Boys and vocational high school students have higher rates. Students generally know electronic cigarette and have more access to it.
9.Early conservative eschar-scraping and delayed skin graft to cure deep burn on the face caused by coal-dust burning and blasting
He-Xian HOU ; Li-Rong WANG ; Qiang WANG ; Bao-Kai LI ; Jia-Bao YANG ; Jun CHEN ; Jun YAN ; Jin-Guang ZHANG ;
Chinese Journal of General Practitioners 2005;0(11):-
Objective To study effective treatment for deep burn on the face caused by coal-dust burning and blasting to prevent severe disfigurement.Methods Early conservative eschar-scraping, delayed skin graft,early strain-diminution for the eyelids in both sides,and wound expansion with skin graft were used to treat 12 patients with deep burn on their faces caused by coal-dust burning and blasting. Results Facial wound of all the 12 patients healed within three weeks after burn.No significant cicatricial hyperplasia and deformity were found on their faces during three-month follow-up,with natural facial expression and abundant emotion.Conclusions Early eschar-scraping and delayed skin graft for deep facial burn can promote fast repair of burn-wound,diminish cicatricial hyperplasia and prevent deformity on the face.
10.Primary spinal melanoma: a case report and literature review.
Liang YAN ; Zhen CHANG ; Yang LIU ; Bao-rong HE ; Ding-jun HAO
Chinese Medical Journal 2012;125(22):4138-4141
This case report describes a 44-year-old woman with primary spinal cord malignant melanoma localized in the lumbar region. This is a very rare lesion. The patient presented with back pain and slight weakness in her lower extremities. Magnetic resonance imaging showed hyperintense signals on T1-weighted images and hypointense signals on T2-weighted images. The entire tumor was removed surgically. The patient's postoperative clinical examination revealed mild neurological improvements. Histopathological investigations confirmed the tumor was a malignant melanoma. When treating common lesions of the lumbar spinal cord with a benign appearance, surgeons should be aware of the potential for malignant tumors.
Adult
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Female
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Humans
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Magnetic Resonance Imaging
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Melanoma
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diagnosis
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Spinal Cord Neoplasms
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diagnosis